Developing the Corporate CMC Regulatory Compliance Strategy
‘We have to move fast because the competition is on our tail; we have limited funds and staff to move our biopharmaceutical through clinical development so we cannot do everything and hire everybody we want; so what CMC must we absolutely have to do now to be successful, and what can we do at a later stage of clinical development?’
KeywordsDrug Product Drug Substance Biopharmaceutical Product Regulatory Submission Biopharmaceutical Company
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